Associate Director, Medical Writing

Corcept Therapeutics seeks an Associate Director of Medical Writing to author and manage clinical regulatory documents supporting drug development programs. The role involves collaborating across functional teams, leading writing projects, and maintaining compliance with US and international regulatory standards.

Responsibilities

• Author, edit, and format clinical regulatory documents including NDAs, protocols, CSRs, and investigator brochures
• Coordinate with cross-functional teams including biometrics, clinical operations, and regulatory affairs on document development
• Develop and manage medical writing timelines and lead comment resolution with stakeholders
• Oversee vendors and contractors; may supervise in-house medical writing staff
• Lead development and refinement of medical writing processes, templates, and quality control standards

Requirements

• Excellent writing and editing skills with knowledge of drug development processes
• Experience with complex clinical and regulatory writing projects across multiple therapeutic areas
• Familiarity with US and European regulatory requirements and e-CTD guidelines
• Strong cross-functional communication and project management abilities
• Attention to detail, multitasking, and prioritization skills
• Understanding of research and development processes and required regulatory documentation